Millar Kathryn, Patel Suha, Munson Meghan, Vesel Linda, Subbiah Shalini, Jones Rachel M, Little Sarah, Papageorghiou Aris T, Villar Jose, Wegner Mary Nell, Pearson Nick, Muigai Faith, Ongeti Catherine, Langer Ana
Department of Family Health Care Nursing, School of Nursing, University of California, San Francisco, San Francisco, CA, United States.
Division of Global Obstetrics and Gynecology, Brigham and Women's Hospital, Boston, MA, United States.
JMIR Res Protoc. 2018 Jun 22;7(6):e10293. doi: 10.2196/10293.
The burden of preterm birth, fetal growth impairment, and associated neonatal deaths disproportionately falls on low- and middle-income countries where modern obstetric tools are not available to date pregnancies and monitor fetal growth accurately. The INTERGROWTH-21 gestational dating, fetal growth monitoring, and newborn size at birth standards make this possible.
To scale up the INTERGROWTH-21 standards, it is essential to assess the feasibility and acceptability of their implementation and their effect on clinical decision-making in a low-resource clinical setting.
This study protocol describes a pre-post, quasi-experimental implementation study of the standards at Jacaranda Health, a maternity hospital in peri-urban Nairobi, Kenya. All women with viable fetuses receiving antenatal and delivery services, their resulting newborns, and the clinicians caring for them from March 2016 to March 2018 are included. The study comprises a 12-month preimplementation phase, a 12-month implementation phase, and a 5-month post-implementation phase to be completed in August 2018. Quantitative clinical and qualitative data collected during the preimplementation and implementation phases will be assessed. A clinician survey was administered eight months into the implementation phase, month 20 of the study. Implementation outcomes include quantitative and qualitative analyses of feasibility, acceptability, adoption, appropriateness, fidelity, and penetration of the standards. Clinical outcomes include appropriateness of referral and effect of the standards on clinical care and decision-making. Descriptive analyses will be conducted, and comparisons will be made between pre- and postimplementation outcomes. Qualitative data will be analyzed using thematic coding and compared across time. The study was approved by the Amref Ethics and Scientific Review Committee (Kenya) and the Harvard University Institutional Review Board. Study results will be shared with stakeholders through conferences, seminars, publications, and knowledge management platforms.
From October 2016 to February 2017, over 90% of all full-time Jacaranda clinicians (26/28) received at least one of the three aspects of the INTERGROWTH-21 training: gestational dating ultrasound, fetal growth monitoring ultrasound, and neonatal anthropometry standards. Following the training, implementation and evaluation of the standards in Jacaranda Health's clinical workflow will take place from March 2017 through March 5, 2018. Data analysis will be finalized, and results will be shared by August 2018.
The findings of this study will have major implications on the national and global scale up of the INTERGROWTH-21 standards and on the process of scaling up global standards in general, particularly in limited-resource settings.
RR1-10.2196/10293.
早产、胎儿生长发育受限以及相关的新生儿死亡负担，在低收入和中等收入国家尤为沉重，这些国家目前尚无现代产科工具来准确确定孕周和监测胎儿生长发育。而INTERGROWTH-21的孕周确定、胎儿生长监测以及出生时新生儿大小标准使得这一切成为可能。
为了扩大INTERGROWTH-21标准的应用范围，评估其在资源匮乏的临床环境中的实施可行性、可接受性及其对临床决策的影响至关重要。
本研究方案描述了在肯尼亚内罗毕城郊的一家妇产医院——蓝花楹健康医院对该标准进行的一项前后对照的准实验性实施研究。纳入2016年3月至2018年3月期间所有接受产前和分娩服务的有存活胎儿的孕妇、她们所生的新生儿以及照料她们的临床医生。该研究包括一个为期12个月的实施前阶段、一个为期12个月的实施阶段以及一个为期5个月的实施后阶段，将于2018年8月完成。将对实施前和实施阶段收集的定量临床数据和定性数据进行评估。在实施阶段的第8个月，即研究的第20个月，进行了一项临床医生调查。实施结果包括对标准的可行性、可接受性、采用情况、适宜性、依从性和渗透率的定量和定性分析。临床结果包括转诊的适宜性以及标准对临床护理和决策的影响。将进行描述性分析，并对实施前后的结果进行比较。定性数据将采用主题编码进行分析，并在不同时间进行比较。该研究已获得阿姆瑞夫伦理与科学审查委员会（肯尼亚）和哈佛大学机构审查委员会的批准。研究结果将通过会议、研讨会、出版物和知识管理平台与利益相关者分享。
2016年10月至2017年2月，蓝花楹健康医院所有全职临床医生（26/28）中超过90%接受了INTERGROWTH-21培训的三个方面中的至少一个方面：孕周确定超声检查、胎儿生长监测超声检查和新生儿人体测量标准。培训后，蓝花楹健康医院临床工作流程中标准的实施和评估将于2017年3月至2018年3月5日进行。数据分析将最终完成，结果将于2018年8月分享。
本研究结果将对INTERGROWTH-21标准在国家和全球范围内的推广以及一般全球标准的推广过程产生重大影响，尤其是在资源有限的环境中。
RR1-10.2196/10293
